MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. IRIX-C CERVICAL INTEGRATED FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	T066-0205
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that during an acdf revision due to nonunion, a forceps implant inserter and a guided angled awl were broken.The initial surgery was reportedly a non-x-spine product.There were no reported patient complications associated with the instrument malfunctions.The following mdrs correspond to this event: 3005031160-2019-00044.The guided angled awl was assessed.The distal tip of the awl was confirmed to be fractured off from the instrument.It was reported that the tip of the guided angled awl broke when the surgeon impacted the ao handle attached to the instrument with a hammer.The guided angled awl and ao handle are at an angle compared to the distal tip of the device.An impact to the ao handle can cause the tip of the awl to break from the instrument.The guided angled awl and ao handle assembly are not intended to be impacted.A dhr review was performed for the guided angled awl and the device met all required specifications prior to initially being released to distribution on 07/02/2014.
Event or Problem Description
The complainant reported that during an acdf revision due to nonunion, a forceps implant inserter and a guided angled awl were broken.The initial surgery was reportedly a non-x-spine product.There were no reported patient complications associated with the instrument malfunctions.The following mdrs correspond to this event: 3005031160-2019-00044.

• Brand Name: IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 9088044
• Report Number: 3005031160-2019-00043
• Device Sequence Number: 11302117
• Product Code: OVE
• UDI-Device Identifier: M697T06602051
• UDI-Public: M697T06602051
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: T066-0205
• Device Lot Number: EM14F003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other